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§170.315(f)(4) Transmission to cancer registries

Version 1.2 Updated on 04-28-2016
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure

01-20-2016
1.1

Removed the reference to Juror Document in (f)(4)(i) Test Lab Verification step 3.  

03-21-2016
1.2

Inserted reference to the Juror Document now available.

04-28-2016
Regulation Text

Regulation Text

§170.315 (f)(4) Transmission to cancer registries

Create cancer case information for electronic transmission in accordance with:

  1. The standard (and applicable implementation specifications) specified in §170.205(i)(2).
  2. At a minimum, the versions of the standards specified in §170.207(a)(4) and (c)(3).

Standard(s) Referenced

Please consult the Final Rule entitled: 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications for a detailed description of the certification criterion with which these testing steps are associated. We also encourage developers to consult the Certification Companion Guide in tandem with the test procedure as they provide clarifications that may be useful for product development and testing.

Note: The order in which the test steps are listed reflects the sequence of the certification criterion and does not necessarily prescribe the order in which the test should take place.
 

Testing components

No GAP Icon Documentation Icon Visual Inspection Icon Test Tool Icon ONC Supplied Test Data Icon

 

Paragraph (f)(4)(i)

System Under Test Test Lab Verification
  1. The user enters the cancer information for each of the test cases referenced from the Home Tab of the CRV. All test cases are required. Note that health IT developers should select the appropriate test case for Test Case 1, based on their module’s capability.
  2. The Health IT Module creates a cancer case document based on the standard specified in §170.205(i)(2), HL7 Implementation Guide for CDA© Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1.1, April 2015, for each test case as outlined below:

Modules that collect radiation treatment data:

  • Test_Case_1a_Complete_Record_With_Radiation

Modules that do not collect radiation treatment data:

  • Test_Case_1b_Complete_Record_Without_Radiation

ALL Health IT Modules :

  • Test_Case_2_Cancer_Diagnosis_With_No_Treatment
  • Test_Case_3_Two_Cancer_Diagnoses
  • Test_Case_4_Two_Cancer_Diagnoses_Update
  • Test_Case_5_Non-reportable
  1. The tester verifies that the Health IT Module includes the source cancer information correctly and without omission through Visual Inspection, using the test data associated with the selected test case.
  2. The tester imports the cancer reports into the test tool for validation based on each test case listed, and uses the Validation Report produced by the test tool to verify the report indicates passing without error to confirm that the cancer report is conformant to the HL7 Implementation Guide for CDA© Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1.1, April 2015.
  3. The tester verifies that the Health IT Module’s supplied cancer document in step 2 is accurate and without omission using the Context-based Validation Report, the Juror Document, and through additional Visual Inspection, checking for equivalent text for:
    1. content for all section level narrative text; and
    2. display names: if the context-based validation indicates a mismatch, equivalent entries are allowable.
  4. Negative Test: For Test_Case_5_Non-reportable, the tester verifies using Documentation that the non-reportable test case does not generate a CDA report

Paragraph (f)(4)(ii)

System Under Test Test Lab Verification

The cancer case information is in accordance with §170.207(a)(4) and §170.207(c)(3).

The tester uses Visual Inspection of the Health IT Module configuration file or Documentation to verify cancer case information are represented using the named §170.207(a)(4) SNOMED CT® standard and the named §170.207(c)(3) (LOINC®) Standard.


Version 1.0 Updated on 10-29-2015
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-29-2015
Regulation Text

Regulation Text

§170.315 (f)(4) Transmission to cancer registries

Create cancer case information for electronic transmission in accordance with:

  1. The standard (and applicable implementation specifications) specified in §170.205(i)(2).
  2. At a minimum, the versions of the standards specified in §170.207(a)(4) and (c)(3).

Standard(s) Referenced

Certification Companion Guide: Transmission to cancer registries

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
 

 

Certification Requirements

Privacy and Security: This certification criterion was adopted at § 170.315(f)(4). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(f) “paragraph (f)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “VDT” and (e)(2) “secure messaging,” which are explicitly stated.

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.

  • When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
  • When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively the developer must state that no accessibility-centered design was used.
Table for Privacy and Security
Technical Explanations and Clarifications

 

Applies to entire criterion

Clarifications:

  • For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
  • This certification criterion is intended for technology designed for the ambulatory setting.
  • We have not adopted a “cancer case information” certification criterion. This decision has no impact on the requirements of the 2015 Edition “transmission to cancer registries” certification criterion or the requirements of the IG. Certification to the 2015 Edition “transmission to cancer registries” criterion requires a Health IT Module to demonstrate that it can create a file with the necessary cancer case information in accordance with the IG. [see also 80 FR 62667]
  • “Cancer case information” is synonymous with the “cancer event reports” or “cancer reports” referred to in the HL7 Implementation Guide (IG) for CDA Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, DSTU Release 1.1.

Paragraph (f)(4)(i)

Technical outcome – The health IT can create cancer case information for electronic transmission in accordance with the HL7 IG for CDA Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, DSTU Release 1.1.

Clarifications:

  • The CDC recently published an updated version of the Implementation Guide for reporting to cancer registries (HL7 IG for CDA® Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1, U.S. Realm) (“Release 1.1.”). Release 1.1 involves technical corrections to Release 1. No new content has been included. We refer developers to the DSTU Release 1.1 for a full list of the updates. [see also 80 FR 62666]
  • Mapping to the North American Association of Central Cancer Registries (NAACCR) format is not included in the IG because the mapping rules are complex, and can change over time based on continued input and refinement by the cancer registry community. It is our understanding that the CDC will work closely with the cancer registry community to develop mapping rules for the IG and will incorporate the rules into the software tools CDC provides state cancer registries. In regard to concerns expressed about jurisdictional variations, all public health jurisdictions have adopted the HL7 IG Release 1 for cancer reporting and will be moving to the updated version published by the CDC. [see also 80 FR 62666]

Paragraph (f)(4)(ii)

Technical outcome – The health IT can create cancer case information for electronic transmission using, at a minimum, the September 2015 Release of the U.S. Edition of SNOMED CT® and Version 2.52 of LOINC®.

Clarifications:

  • We provide the following OIDs to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
    • SNOMED CT® OID: 2.16.840.1.113883.6.96
    • LOINC® OID: 2.16.840.1.113883.6.1 [see also 80 FR 62612]
  • Health IT Modules can present for certification to a more recent version of SNOMED CT®, U.S. Edition than the September 2015 Release and a more recent version of LOINC® than Version 2.52 per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]

Regulation Text

Regulation Text

§170.315 (f)(4) Transmission to cancer registries

Create cancer case information for electronic transmission in accordance with:

  1. The standard (and applicable implementation specifications) specified in §170.205(i)(2).
  2. At a minimum, the versions of the standards specified in §170.207(a)(4) and (c)(3).

Criterion Subparagraph Test Data
(f)(4)(i)
Content last reviewed on February 21, 2018
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